%0 Journal Article
%T Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.
%A Riedl MA
%A Maurer M
%A Bernstein JA
%A Banerji A
%A Longhurst HJ
%A Li HH
%A Lu P
%A Hao J
%A Juethner S
%A Lumry WR
%A
%J Allergy
%V 75
%N 11
%D 11 2020
%M 32452549
%F 14.71
%R 10.1111/all.14416
%X Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.
To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.
One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.
Protection with lanadelumab started from the first dose and continued throughout the entire study period.